United Zirconia · Class II · Cleared May 12, 2025
| K-number | K250393 |
| Device name | ZircaGlow & ZircaGlow HT Zirconia |
| Applicant | United Zirconia |
| Product code | EIH |
| Device class | Class II |
| Decision date | May 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.6660 |
ZircaGlow and ZircaGlow HT Zirconia are dental prosthetic blanks composed of yttria-stabilized zirconia ceramics. Dental technicians mill these disc-shaped blanks using CAD/CAM technology to create custom full-contour crowns, bridges, and copings up to a full arch, which are then sintered and fitted to patients' teeth.
Both ZircaGlow variants use zirconia ceramic (ZrO₂+HfO₂+Y₂O₃ >99.9 wt%) with sintered density ≥6.04 g/cm³. ZircaGlow has bending strength ~1085-1138 MPa and fracture toughness 8.1-8.5 MPa√m; ZircaGlow HT has lower bending strength (~956-963 MPa) but higher fracture toughness (8.4-8.7 MPa√m), reflecting higher yttria content (7.6% vs 5.6%). Both meet ISO 6872:2024 Class 5 requirements and have thermal expansion coefficient of 10.5 µm/m°C.
ISO 6872:2024 (Dentistry – Ceramic materials), ISO 13356:2015 (Implants for surgery, ceramic materials based on yttria-stabilized tetragonal zirconia Y-TZP), and ISO 10993-1:2018 (Biological evaluation of medical devices).
The subject device matches the predicate (ArgenZ HT+ K190079) in composition (>99.9 wt% ZrO₂+HfO₂+Y₂O₃), manufacturing (pressed and sintered zirconia blanks), indications (full contour and substructure restorations up to full arch), and form factor (disc shapes). Both achieve >800 MPa flexural strength and >5.0 MPa√m fracture toughness, satisfying ISO 6872:2024 Class 5 monolithic-ceramic standards. Biocompatibility is assured through identical material composition and manufacturing processes. Minor performance differences between the two formulations do not raise new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov